Anchored non-piercing duodenal sleeve and delivery systems

ABSTRACT

An intragastric implant for obesity treatment is disclosed. The device delays digestion by providing a duodenal sleeve, and may also slows gastric emptying by limiting flow through the pyloric sphincter. The implant includes an elongated axially-compressible duodenal sleeve having a non-tissue-piercing anchor on a proximal end sized to lodge within the duodenal bulb. The anchor may have oppositely-directed anchoring flanges to resists migration in both directions. The sleeve may also have barbed ribs to resist proximal movement back up into the stomach. A method of implant includes collapsing/compressing the device and transorally advancing it through the esophagus to be deployed within the duodenum. A dissolvable jacket may constrain the implant for delivery and naturally dissolve upon implant. Removal of the implant may occur in the reverse.

RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 13/921,082 filed Jun. 18, 2013 which is a continuation of U.S.patent application Ser. No. 13/276,208 filed Oct. 18, 2011, which claimspriority under 35 U.S.C. § 119 to U.S. Provisional Application No.61/479,714, filed Apr. 27, 2011, to U.S. Provisional Application No.61/485,009, filed May 11, 2011, and to 61/394,592, filed Oct. 19, 2010,the disclosures of which are incorporated by reference herein.

FIELD OF THE INVENTION

The present invention is directed to intragastric devices used for thetreatment of obesity, and in particular to duodenal sleeves having anon-piercing anchor and delivery systems therefor.

BACKGROUND OF THE INVENTION

Over the last 50 years, obesity has been increasing at an alarming rateand is now recognized by leading government health authorities, such asthe Centers for Disease Control (CDC) and National Institutes of Health(NIH), as a disease. In the United States alone, obesity affects morethan 60 million individuals and is considered the second leading causeof preventable death. Worldwide, approximately 1.6 billion adults areoverweight, and it is estimated that obesity affects at least 400million adults.

Obesity is caused by a wide range of factors including genetics,metabolic disorders, physical and psychological issues, lifestyle, andpoor nutrition. Millions of obese and overweight individuals first turnto diet, fitness and medication to lose weight; however, these effortsalone are often not enough to keep weight at a level that is optimal forgood health. Surgery is another increasingly viable alternative forthose with a Body Mass Index (BMI) of greater than 40. In fact, thenumber of bariatric surgeries in the United States is projected to reachapproximately 400,000 annually in 2010.

Examples of surgical methods and devices used to treat obesity includethe LAP-BAND® (Allergan, Inc., Irvine, Calif.) gastric band and theLAP-BAND AP® (Allergan, Inc., Irvine, Calif.). However, surgery mightnot be an option for every obese individual; for certain patients,non-surgical therapies or minimal-surgery options are more effective orappropriate.

Intragastric balloons are also well known in the art as a means fortreating obesity. One such inflatable intragastric balloon is describedin U.S. Pat. No. 5,084,061 and is commercially available as theBioEnterics Intragastric Balloon System (sold under the trademark BIB®System). These devices are designed to provide therapy for moderatelyobese individuals who need to shed pounds in preparation for surgery, oras part of a dietary or behavioral modification program. The BIB System,for example, consists of a silicone elastomer intragastric balloon thatis inserted into the stomach in an empty or deflated state andthereafter filled (fully or partially) with a suitable fluid. Theballoon occupies space in the stomach, thereby leaving less room forfood and creating a feeling of satiety for the patient.

Another type of surgical device for treating obesity is a duodenalsleeve, which is a flexible tube endoscopically placed in and along theduodenum, which is located at the beginning of the intestinal tract, toslow down or interrupt the digestive process which occurs there.Examples of such devices include those shown in U.S. Pat. No. 5,820,584to Crabb and U.S. Pat. No. 7,476,256 to Meade, et al. Duodenal sleevesrequire some sort of anchor to prevent migration down the intestinaltract, typically utilizing a metallic stent with barbs as in the Meadepatent and as described in “First human experience with endoscopicallydelivered and retrieved duodenal-jejunal bypass sleeve,”Rodriguez-Grunert, et al., Surgery for Obesity and Related Diseases,4:57-59 (2008).

Despite many advances in the design of intragastric obesity treatmentdevices, there remains a need for an improved duodenal sleeve that canbe implanted for longer periods than before or otherwise address certaindrawbacks of previous devices.

SUMMARY OF THE INVENTION

The present invention addresses the above-described problems byproviding a transorally inserted, intragastric device for the treatmentof obesity. The device includes a sleeve for placement in the duodenumhaving a tubular body with proximal and distal ends. A radiallycollapsible anchor surrounds the proximal end of the tubular body, theanchor having an expanded state that can act to prevent passage of thedevice through the pyloric sphincter. The anchor further includes twoconical flanges concentrically-disposed around the tubular body andangled away from one another so as to impede movement of the anchorwithin the duodenum in both a proximal direction and in a distaldirection. The device is formed of a material that will resiststructural degradation over a period of at least six months within thegastrointestinal tract. Preferably, the sleeve is axiallycollapsible/expandable and includes exterior ribs to resist movementwithin the duodenum in one direction. The exterior ribs on the sleevemay be conical and extend the length of the sleeve and angle in theproximal direction to resist movement within the duodenum in theproximal direction. In one embodiment, the conical ribs are shaped tonest within one another for axial collapse of the sleeve. In aparticularly preferred form, the anchor surrounding the proximal end ofthe tubular body has no metal component.

Another aspect of the present application is a transorally inserted,intragastric device for the treatment of obesity. The device has astomach anchoring member with a collapsed, delivery size, and anexpanded, deployed size larger than a pyloric sphincter, the stomachanchoring member having no tissue-piercing elements. A duodenalanchoring member has a collapsed, delivery size, and an expanded,deployed size larger than a pyloric sphincter, the duodenal anchoringmember also has no tissue-piercing elements. Further, an elongatedduodenal sleeve for placement in the duodenum has a tubular body withproximal and distal ends, the proximal end extending to the stomachanchoring member on the stomach side of the pyloric sphincter andforming a compressible channel through the pyloric sphincter. Finally, aplurality of cords extends the length of the device from the stomachanchoring member to the distal end of the duodenal sleeve. The device isformed of a material that will resist structural degradation over aperiod of at least six months within the gastrointestinal tract.

In the preceding intragastric device, the anchoring member may comprisea funnel-shaped structure that extends into the stomach, wherein theduodenal sleeve continues and widens in a proximal direction along thefunnel-shaped structure. The stomach anchoring member may be formed by aplurality of resilient rings sufficiently compressible to be deliveredtransorally, and sufficiently large to spring outward to form thefunnel-shaped structure in contact with the antrum area of the stomach.The duodenal anchoring member may also be formed by resilient ringssufficiently compressible to be delivered transorally, and sufficientlylarge to spring outward into contact with a duodenal bulb area of theduodenum. In one embodiment, the plurality of resilient rings aredifferently sized and having a central larger ring such that theduodenal sleeve has a bulge in the area of the duodenal anchoringmember. The device further may include a plurality of spaced resilientrings along the duodenal sleeve and connected to the cords foranti-migration/anti-kinking characteristics. Also, the device may have aflexible annular membrane spanning the stomach anchoring member andhaving a central through hole that defines the flow orifice from thestomach into the duodenal sleeve. Preferably, a plurality of graspingtabs project proximally from the stomach anchoring member, and the tabsmay be proximal ends of the cords.

Another transorally inserted, intragastric device for the treatment ofobesity comprises a stomach anchoring member with at least one resilientring sufficiently compressible to be delivered transorally andsufficiently large to spring outward into contact with the lower stomachadjacent the pyloric sphincter. A duodenal anchoring member has aplurality of resilient rings sufficiently compressible to be deliveredtransorally, and sufficiently large to spring outward into contact witha duodenal bulb area of the duodenum. In addition, an elongated duodenalsleeve for placement in the duodenum has a tubular body with proximaland distal ends, the proximal end extending to the stomach anchoringmember on the stomach side of the pyloric sphincter, and forming acompressible channel through the pyloric sphincter. Again, the deviceresists structural degradation over at least six months within thegastrointestinal tract.

The stomach anchoring member may be a funnel-shaped structure thatextends into the stomach, wherein the duodenal sleeve continues andwidens in a proximal direction along the funnel-shaped structure. In oneembodiment, the stomach anchoring member comprises a plurality of theresilient rings forming a funnel-shaped structure in contact with theantrum area of the stomach. The device may have a flexible annularmembrane spanning the resilient ring of the stomach anchoring member andhaving a central through hole that defines the flow orifice from thestomach into the duodenal sleeve. In the embodiment where the stomachanchoring member comprises a plurality of the resilient rings sizedprogressively larger in the proximal direction to form a funnel-shapedstructure that extends into the stomach, the flexible annular membranespans the resilient ring closest to the duodenal anchoring member. Aplurality of grasping tabs may project proximally from the stomachanchoring member, and the grasping tabs desirably comprise proximal endsof the cords. The plurality of resilient rings of the duodenal anchoringmember preferably spring outward into contact with a duodenal bulb areaof the duodenum and are differently sized, having a central larger ringsuch that the duodenal sleeve has a bulge in the area of the duodenalanchoring member. The device preferably includes a plurality of spacedresilient rings along the duodenal sleeve and connected to the cords foranti- for migration/anti-kinking characteristics.

A still further passive intragastric obesity treatment implant disclosedherein comprises an umbrella member having expanded diameter sufficientto prevent passage through the pyloric sphincter, the umbrella memberbeing formed of a plurality of longitudinal struts. A duodenal anchorconnects to one end of the umbrella member, the duodenal anchor having asize that permits it to pass through the pyloric sphincter and be formedof a material of sufficient mass and specific gravity that prevents itfrom migrating back up through the pyloric sphincter. The implant isformed of a material which permits it to be compressed into asubstantially linear delivery configuration and that will resistdegradation over a period of at least six months within the stomach.

Another aspect of the application is a transorally inserted,intragastric device for the treatment of obesity comprising a sleeve forplacement in the duodenum having an axially collapsible tubular bodywith proximal and distal ends. A radially collapsible anchor surroundsthe proximal end of the tubular body and has a radially expanded statethat prevents passage through the pyloric sphincter. The anchorincluding exterior features to resist movement within the duodenum inboth proximal and distal directions. The device is formed of a polymericmaterial absent of any metal that will resist structural degradationover a period of at least six months within the gastrointestinal tract.Preferably, the sleeve includes exterior ribs to resist movement withinthe duodenum in one direction. The exterior ribs on the sleeve may beconical and extend the length of the sleeve and angle in the proximaldirection to resist movement within the duodenum in the proximaldirection. In one embodiment, the conical ribs are shaped to nest withinone another for axial collapse of the sleeve. In a particularlypreferred form, the anchor surrounding the proximal end of the tubularbody has no metal component. The exterior features on the anchor may betwo conical flanges concentrically-disposed around the tubular body andangled away from one another.

A further aspect disclosed herein is a transorally inserted,intragastric system for the treatment of obesity. The system has animplant with a sleeve for placement in the duodenum having an axiallycollapsible tubular body with proximal and distal ends. A radiallycollapsible anchor surrounding the proximal end of the tubular body hasa radially expanded state that prevents passage through the pyloricsphincter. The implant is formed of a material that will resiststructural degradation over a period of at least six months within thegastrointestinal tract. Finally, a jacket is sized to surround andretain the implant in its collapsed configuration, the jacket beingeasily removable from around the implant. Preferably, the sleeveincludes exterior ribs to resist movement within the duodenum in onedirection.

Desirably, the exterior ribs on the sleeve may be conical and extend thelength of the sleeve and angle in the proximal direction to resistmovement within the duodenum in the proximal direction. In oneembodiment, the conical ribs are shaped to nest within one another foraxial collapse of the sleeve. In a particularly preferred form, theanchor surrounding the proximal end of the tubular body has no metalcomponent. The anchor may include two conical flangesconcentrically-disposed around the tubular body and angled away from oneanother so as to resist movement of the anchor within the duodenum inboth proximal and distal directions. Preferably, the anchor surroundingthe proximal end of the tubular body has no metal component. The jacketmay have a rounded closed distal end, and an open proximal end. Thejacket may be dissolvable. The jacket preferably has a first lengthsurrounding the sleeve and a second length surrounding the anchor whichis stronger than the first length.

A further understanding of the nature and advantages of the inventionwill become apparent by reference to the remaining portions of thespecification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the present invention will become appreciatedas the same become better understood with reference to thespecification, claims, and appended drawings wherein:

FIG. 1 is a sectional view through a human stomach illustrating anexemplary intragastric obesity treatment implant having a duodenalsleeve deployed in the duodenum and a dual-flanged anchor positioned inthe duodenal bulb area, just distal to the pyloric sphincter;

FIG. 2 is a close up view of the duodenal bulb area with theintragastric obesity treatment implant expanded to its as-molded shape;

FIGS. 3A-3D show the proximal end of the expanded intragastric obesitytreatment implant in its as-molded shape to help visualize the device;

FIG. 4 illustrates the intragastric obesity treatment implant afterremoval from a shipping package in its collapsed/compressed state withina delivery jacket as it would look before inserting down the esophagus;

FIG. 5 shows the collapsed/compressed intragastric obesity treatmentimplant on the end of a flexible delivery member inserted down theesophagus and poised for advancement through the pyloric sphincter intoan implant position;

FIGS. 6A-6D show the collapsed/compressed intragastric obesity treatmentimplant within a flexible delivery tube inserted down the esophagus andexpelled for subsequent advancement through the pyloric sphincter intoan implant position;

FIGS. 7 and 8 are perspective views of an intragastric obesity treatmentdevice that can be used to form an artificial stoma;

FIG. 9 illustrates an expandable umbrella having a duodenal anchorpositioned in the stomach, and FIG. 9A is an enlarged view thereof;

FIGS. 10 and 10A show an intragastric obesity treatment device implantedin the stomach with a flow channel spanning the pyloric sphincter and aduodenal sleeve;

FIGS. 11 and 12A-12C illustrate another intragastric device implanted inthe stomach with a flow channel spanning the pyloric sphincter and aribbed duodenal sleeve;

FIG. 13 illustrates another intragastric device implanted in the stomachspanning the pyloric sphincter and having a duodenal sleeve, while FIG.14 shows the device isolated and with the duodenal sleeve removed forclarity; and

FIG. 15 shows a still further intragastric device in the stomach similarto that shown in FIG. 13, but having an enlarged funnel-like anchor inthe lower stomach, and FIG. 16 shows the device isolated with theduodenal sleeve removed for clarity.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is directed to intragastric devices for passivelytreating obesity by limiting nutrient absorption/caloric assimilation.Furthermore, the exemplary device described herein may affect the rateof stomach emptying. The term “passive” refers primarily to a lack ofany moving parts within the devices, but in general to the inert natureof the various devices.

FIG. 1 illustrates an exemplary intragastric obesity treatment implant20, but also illustrates the anatomy of the human stomach, which will bedescribed first. The major function of the stomach S is to temporarilystore food and release it slowly into the duodenum D. The esophagus Eextending downward from the mouth connects to the stomach via esophagealsphincter ES, which regulates flow food into the stomach cavity. Thecardia C surrounds the superior opening of the stomach. The roundedportion superior to the body B and adjacent the cardia is the fundus F.Inferior to the fundus is the large central portion of the stomach,called the body that is lined with muscles that contract and relaxrepetitively to churn the food therein. The stomach processes the foodto a semi-solid “chyme,” which enables better contact with the mucousmembrane of the intestines, thereby facilitating absorption ofnutrients. In addition, the stomach is an important site of enzymeproduction.

Lower down in the stomach the antrum A connects the body to the pylorisP, which leads into the duodenum. Below the stomach, the duodenum leadsinto the upper part of the small intestine (not shown); the jejunum Jmakes up about one-third of the small intestine. The region of thestomach that connects to the duodenum is the pylorus. The pyloruscommunicates with the duodenum of the small intestine via the pyloricsphincter PS (valve). This valve regulates the passage of chyme fromstomach to duodenum and it prevents backflow of chyme from duodenum tostomach.

FIG. 1 illustrates the exemplary intragastric obesity treatment implant20 having a duodenal sleeve 22 deployed in the duodenum and adual-flanged anchor 24 positioned in the duodenal bulb area, just distalto the pyloric sphincter PS. This application discloses a single usegastrointestinal (GI) implant that resides inside the duodenum D. It hasbeen demonstrated that duodenal sleeves, as this device may beclassified, limit food contact against the intestinal walls. It is knownthat most nutrient absorption occurs within the duodenum D. The devicelines the duodenal walls, and possibly the jejunum J, and is anticipatedto limit nutrient absorption/caloric assimilation, thereby inducingweight loss. More particularly, the duodenal sleeve 22 desirably lines(i.e. contacts) the upper duodenal wall, partially preventing nutrientabsorption by inhibiting or delaying the point at which chyme from thestomach contacts the mucous membranes of the intestine.

The entire device is formed of a material that will resist structuraldegradation over a period of at least six months within the stomach. Inthis context, the term “structural degradation” means that the devicewill retain structural integrity sufficiently to perform its intendedfunction for a desired time period, for example 6 months. In one sense,the device is nonbiodegradable for the desired time period, though somebiodegradation may commence short of structural degradation. The anchor24 is to be made of a compliant plastic material, and is desirablyintegrally molded with the rest of the device. The anchor is configuredto gently expand against the walls of the duodenal bulb. The anchor andindeed the implant 20 has no metal pieces (i.e., is absent of anymetal), which have sometimes been found to cause AE's, since metal hasbeen seen to ulcerate GI tissues, especially when applying constantpressure. It is even possible that metal features can push through theduodenal walls, breaching the body's sterile barrier and causing death.As a result, no piercing of the stomach or intestinal walls is requiredto anchor this device, and it may be implanted in a minimally invasivemanor, through the esophagus, without any surgical procedure. Thisdevice requires no tissue modifications, and may be removed at any time.

FIG. 2 is a close up view of the duodenal bulb area and intragastricobesity treatment implant 20 expanded to its as-molded shape. The term“as-molded shape” refers to the expanded shape of the implant 20 as itwould appear after fabrication and in the absence of any surroundingconstriction. It should be apparent to the reader that after expansionwithin the duodenum D the implant 20 expands until it contacts thesurrounding duodenal walls, and as such is subject to a certain amountof constriction. However, the implant 20 is fabricated to have a sizejust slightly larger than the duodenum and duodenal bulb area, and assuch can be viewed as expanding if not completely to, almost to its“as-molded shape.” Stated a different way, the “as-molded shape” refersto the expanded shape of the implant 20 either in the absence ofconstriction or as implanted and shown in the drawings.

FIGS. 3A-3D show enlarged details of the proximal end of theintragastric obesity treatment implant 20 in its as-molded shape to helpvisualize the device. The duodenal sleeve 22 is substantially tubularwith a smooth inner lumen 26 open on both ends and a rough or barbedouter surface. In a preferred embodiment, the outer surface features aseries of evenly spaced fully circular barbed ribs 28 that protrudeoutwardly in the proximal direction from the thin walls of the sleeve.Specifically, each of the ribs 28 includes a relatively shallowly-angledconical distal surface 30 terminating at a circular tip 32 leading to asubstantially more steeply-angled conical proximal surface 34. The ribs28 extend in series along the length of the duodenal sleeve 22 from adistal end of the sleeve to the proximal dual-flanged anchor 24.

The series of ribs 28 serve three purposes. First, they providecircumferential stiffness to the sleeve 22, which is very thin and mostflexible between each rib. Secondly, the “sharp”, thin edges of the ribsare angled in a proximal direction, so as to grip the duodenal walls ina mode that is most prone to proximal movement. The series of ribs 28thus provides a soft one-way anchor for the duodenal sleeve 22 thatresists migration in a proximal direction, or toward the stomach, duringroutine digestive peristaltic action when implanted in the duodenum D.The third purpose of the ribs 28 is to “nest” together closely when theimplant 20 in its collapsed/compressed state.

The material of the implant 20 desirably has elasticity so that theimplant may be compressed both longitudinally (the sleeve 22) andradially (the anchor 24). As will be explained below, a constraint isplaced on the implant 20 for transoral delivery down the esophagus E tothe duodenum D. In a preferred embodiment, the constraint is releasedand the implant 20 spontaneously expands into contact with thesurrounding duodenal walls. With respect to the duodenal sleeve 22, theexpansion may alternatively be assisted by a device that contacts itsdistal end and is used to pull the distal end away from the proximal end(which may be anchored in the duodenal bulb or held by a proximal end ofthe delivery device) to stretch the sleeve. As such, the material andconfiguration of the sleeve 22 may be biased toward expansion withoutnecessarily being capable of immediate self-expansion. An analogy forthis is a ribbed straw for drinking which may be pulled or bent into anangle.

With reference back to FIGS. 3A-3D, the proximal end of the duodenalsleeve 22 forms a non-tissue-piercing anchoring portion 24 that seatsinside the duodenal bulb and is intended to limit migration down theintestines, or back into the stomach. The soft dual-flanged anchor 24has a conical proximal flange 36 a angled in a proximal direction and aconical distal flange 36 b connected at its base to the proximal flangeangled in a distal direction. Both flanges 36 a, 36 b have “sharp” edgesand thicker base legs. That is, the flanges taper from a wide base 38 tonarrow circular edges 40. The oppositely angled proximal and distalflanges 36 a, 36 b help resist fore and aft movement of the implant 20.However, the absence of any metal and soft nature of the flange materialprevents piercing of the surrounding duodenal wall and helps resistirritation.

The proximal anchor 24, and in particular the proximal conical flange 36a, forms an intake funnel 42 that leads to the lumen 26 of the duodenalsleeve 22. The smallest diameter of the funnel 42, which preferablycoincides with the constant diameter of the lumen 26, may be sized toreduce the volume flow rate exiting the stomach S through the pyloricsphincter PS. With reference to FIG. 2, the pyloric sphincter PS asshown in a contracted state, but regularly expands to permit boluses ofchyme to pass therethrough. The funnel 42 and lumen 26 provide a maximumdiameter passageway which may be designed to be smaller than the maximumexpanded diameter of the pyloric sphincter PS. As such, the implant 20thus may reduce the rate of stomach emptying, further contributing toweight loss.

FIG. 4 shows the exemplary intragastric obesity treatment implant 20′ ina collapse/compressed state such as after removal from a shippingpackage, while FIG. 5 shows the collapsed/compressed implant 20 on theend of a flexible delivery member 60 inserted down the esophagus E andpoised for advancement through the pyloric sphincter PS. The implant 20′is shown constrained by a delivery jacket 50 as it would look beforeinserting down the esophagus E. The delivery jacket 50 includes aproximal collar 52 which surrounds the proximal anchor 24 (not shown)may be formed with somewhat more strength than the jacket 50 to radiallyconstrain the larger flanges 36 a, 36 b. Indeed, the jacket 50 may besized so as to just axially collapse the duodenal sleeve 22, or it mayalso radially compress the sleeve. The jacket 50 is intended toconstrain the sleeve 22 during delivery through the esophagus E, andthus a maximum delivery diameter may be derived from experience anddepending on the patient which is suitable for only axially collapsingthe sleeve. The jacket 50 is closed at a rounded distal end 54 to easedelivery through the winding esophagus, stomach, and duodenum. Alubricant may be used to facilitate this advancement.

In one particular configuration the delivery jacket 50 may be made of agel that rapidly dissolves in the stomach environment. One example of agel material suitable for the jacket 50 is the type of gel used for gelcaps for ingestible pills. The dissolvable gel may be similar to capsused in pills for medicating large animals, and is completely inert tothe human body. In the GI acid environment, the gel will dissolve ratherquickly. Dissolution can even be accelerated to attain a pre-determinedholding time by adding a series of holes through the gel wall, andvarying their size, spacing, and number accordingly. However, a gel thatbetter withstands the environment of the stomach and gastrointestinaltract for a short period is preferred. If the collapsed/compressedlength of the implant 20 is such that the device remains partly in andpartly out of the stomach, then a gel or other material that retains itsintegrity around the device during the delivery procedure is needed. Forinstance, a material that breaks down after about 5-10 minutes in thestomach would be appropriate.

In another configuration, the jacket 50 may not be dissolvable, butinstead may be removed from around or pulled off the implant 20 when inposition in the duodenum D. For instance, the flexible delivery member60 may include a first portion that grasps the implant 20, and a secondportion movable with respect to the first portion that can pull thejacket 50 in a proximal direction. The rounded distal end 54 may betearable or dissolvable to facilitate removal of the jacket 50, or thedistal end may be open with an elastic cincture to hold the sleeve 22 ina collapsed state. Furthermore, other ways to constrain the implant 20are contemplated, including a more substantial overtube from which theimplant is expelled and the like, as will be described below. Theimplant itself should not be considered limited to a particular deliverymethodology.

In a typical procedure, the entire sleeve 22 may be accordion-compressedover the axially-stiff but laterally flexible installation/guide-tube60. Before packaging, the device is fully compressed and held in itscompressed state, while the delivery jacket 50 is placed over the distalend. The jacket 50 need not be closed on its proximal end. In thisconfiguration, the device is ready for implantation.

Device delivery desirably occurs as follows: First, the compressed,gel-covered implant 20 would be routed down the esophagus by aid of itsattached guide tube 60 or within a cannula device (not shown). Thephysician temporarily halts advancement of the implant 20 at the distalend of the stomach S, adjacent to the pylorus P. The implant 20 could bemanufactured to include a radiopaque material such as Barium Sulphatefor x-ray visualization at any present or future time. A fluoroscopewould be utilized to visualize placement during the implantationprocedure. No endoscope need be used. When located adjacent to thepylorus P, the physician pushes the implant 20 firmly through thepyloric sphincter PS, using the guide tube 60, and into the duodenalbulb. The implant 20 would then be held in that location until the geljacket 50 begins to dissolve. Alternatively, the jacket 50 is removedfrom around the implant 20. The proximal dual-flange anchor 24 thenimmediately expands within the duodenal bulb, fixing the device inplace, and thus limiting movement in either direction. Normalperistaltic action would then be relied on to fully deploy the sleeve“automatically”, into its fully expanded state down the duodenum.Alternatively, as mentioned above, an obturator attached to the distalend of the sleeve 22 may be advanced to assist axial deployment thereof.The device is then left in place for a predetermined length of time,such as 6 months, while the patient is monitored for weight loss and anysigns of malfunction.

FIGS. 6A-6D show an alternative delivery of the implant 20 using aflexible delivery tube 70 inserted down the esophagus E. In FIG. 6A thedelivery tube 70 has entered the stomach through the esophagealsphincter ES and the distal end of the duodenal sleeve 22 projects fromits distal end. As will be seen, a pusher or grasper may be used toadvance the implant 20 relative to the delivery tube 70. Typically, anendoscope passed parallel with or through the delivery tube 70 is usedto visualize the locations of the delivery tube and implant, but willnot be shown for clarity.

FIG. 6B illustrates advancement of the distal end of the distal portionof the duodenal sleeve 22 through the pyloric sphincter PS and into theduodenum D (again, typically with the aid of an endoscope). It should benoted that the implant 20 is shown in an expanded state in thissequence, but essentially the same steps could be used to delivery acollapsed/compressed implant. A distal end of a grasper 72 is seenholding the anchor 24 of the implant 20, which is one way to push thedevice through the tube 70.

FIG. 6C then shows the implant 20 fully advanced to its implantposition. The grasper 72 remains holding and compressing the anchor 24so that it may fit through the pyloric sphincter PS. Again, analternative method is a jacket that maintains constriction around theanchor 24.

Finally, FIG. 6D shows the implant 20 fully deployed, with the anchor 24expanded outward into contact with the duodenal bulb, as in FIGS. 1 and2. The grasper 72 retracts back up the delivery tube 70, and the tube isthen withdrawn to complete the implant procedure.

A removal procedure consists of placing a long overtube down theesophagus E such that the tube ends reach from the mouth and into thestomach S. Next, a long-handled grasping tool or specially made removaldevice should be inserted down the overtube. By operating the grasper tograsp onto the inside of the anchoring portion 24, the implant 20 can begently pulled, so as to guide it back through the pylorus and into theovertube. Pulling on the implant 20 continues until the grasped anchorend 24, along with the entire trailing sleeve 22 has been removedthrough the mouth. It is anticipated that this removal procedure willcause only slight throat irritation from the overtube, but will notinduce excessive trauma.

The intragastric obesity treatment implant 20 is intended to be a singleuse implant placed in the stomach transorally without invasive surgery,and recovery time is believed to be minimal. The device may desirably beleft in place one year or longer, which is somewhat material-dependentin the acidic stomach environment.

Another device 120 that regulates the amount of food allowed to passfrom the stomach into the duodenum is seen in FIGS. 7 and 8 andcomprises an artificial stoma. The device includes a tubular stent 122for anchoring in a passage and a stoma diaphragm 124 that extendsperpendicularly over one end of the stent. The diaphragm 124 defines astoma opening 126 and may be provided with fold lines such as seen at128 in FIG. 8 for easy collapse.

The device 120 is designed to be placed inside the stomach, just abovethe pylorus. The stent 122 contacts the stomach cavity walls and thestoma diaphragm 124 acts to regulate the amount of food allowed to passfrom the stomach into the duodenum, thus slowing stomach emptying. Thedevice 120 also exerts some pressure upon the lower part of the stomach.

With the device 120 of FIGS. 7 and 8, hole-size restriction is believedto slow emptying of partially digested food from one organ to the next.The placement will not have as great a potential for causing GERD(Gastro Esophageal Reflux Disease) since stomach installation is belowthe esophageal sphincter (within the lower stomach), unlike certaindevices configured for placement at the esophageal sphincter.

The outside diameter of the stoma is constructed in one size. Severalfixed hole sizes may be made available to allow various restrictedamounts of food to pass into the stomach. For instance, three fixed ODsizes are believed sufficient designed to fit within lower esophagus ofmost patients. Small (12 mm), medium (15 mm), and large (18 mm) stomaopenings are provided depending on the patient's needs. Additionally, asingle, optimized OD size could be made, that would universally suit allpatients.

A temporary, removable surgical obturator 130 (FIG. 7) is used to holdthe stent in a compressed state, so it will fit comfortably down theesophagus. Anchoring is achieved within the pyloric sphincter by selfexpansion.

FIG. 9 shows a further intragastric obesity treatment device 175implanted in the stomach having an expandable umbrella-shaped conicalanchor 176 with a duodenal anchor 177. The device 175 is designed tospan the pyloric sphincter, and is shown in more detail in FIG. 9A. Thedevice 175 anchors on the stomach side of the pyloric sphincter with theumbrella-shaped anchor 176, which desirably comprises an expandablestent-like device. The anchor 176 incorporates features (e.g.metal/plastic mesh) that will give it structure which will help preventits migration through the pylorus. The distal side consists of asleeve-like anchor 177 which incorporates features on its outer surface,such as shoulder 178, which prevent migration back into the stomach. Aninternal passage along the entire device, which includes a narrow neckportion 179, allows food to pass therethrough, although with somerestriction which delays gastric emptying. Narrowing of the neck portion179, and possibly a collapsible construction, provides little resistanceto closing action of the pyloric sphincter. At the terminal end of thedevice, a fixed size stoma (not shown) may be provided which furtherdelays gastric emptying. The duodenal anchoring sleeve 177 also providesa barrier across which there can be no nutrient transfer to the body.The main mode of action of this device is malabsorptive (limits nutrienttransfer to body through duodenum). A second mechanism is this device'spotential ability to delay gastric emptying, thereby facilitating arapid achievement of satiety as the stomach fills (but does not empty asfast as normal) and also prolonging the feeling of satiety once reached.

FIGS. 10 and 10A show an intragastric obesity treatment device 180implanted in the stomach that shares some similarities with the device175 of FIG. 9 in that it creates a flow channel spanning the pyloricsphincter and has a duodenal sleeve. More particularly, the device 180provides an inflatable anchor 181 that sits against the pylorus andprevents the device from passing entirely through the pyloric sphincter.A second balloon 182 somewhat smaller than the first sits just insidethe duodenum. The balloons 181, 182 seat on both sides of the pylorusand serve as anti-migration features so the device 180 cannot migratedown through the intestines or back into the stomach. The balloons 181,182 include through bores and narrow passageway 183 extends between themat the pyloric sphincter. Since the material is soft and thin-walledmaterial, the pyloric sphincter is able to close over the passageway183, allowing it to “seal” shut.

In addition to the two balloons, an inflatable sleeve 184 fixed at itsproximal end to the second balloon 182 extends down the duodenum. Thisis a malabsorptive sleeve that prevents nutrient absorption in thejejunum. The sleeve 184 is inflatable which provides means forpositioning and anchoring. More particularly, the sleeve 184 consists ofdual walls 185, 186 that form an inflatable bladder along the shaft ofthe sleeve, so there are inner and outer sleeve walls, closed at bothends, while the sleeve inner lumen remains hollow and open. Inflation ofthe sleeve 184 is an anti-rotational feature within the jejunum and alsohelps prevent “bunching-up” and twisting.

The three inflatable members of the balloon 181, 182 and sleeve 184could be connected or separate (not air or fluid communicating). Theentire device can be inflated with air or liquid. The sleeve 184 passesthrough the dual balloons 181, 182 and into the stomach, so food isallowed to flow freely from the stomach, directly to the lowerintestine, where nutrient absorption is less. On that basis, weight lossis achieved.

As mentioned before, a number of independent characteristics disclosedfor the various embodiments included herein may be transferred to otherembodiments. For example, several versions of the intragastric obesitytreatment device included a threaded bore to mate with a threaded end ofan obturator for delivering and removing the device to and from thestomach (e.g., FIG. 9). Likewise, a similar arrangement can also beincluded on embodiments where it is not specifically shown.

FIG. 11 shows another intragastric device 190 implanted in the stomachwith a conical anchor 192 securing an upper end of a ribbed duodenalsleeve 194 that lines the upper duodenal wall. The duodenal sleeve 194partially prevents nutrient absorption by inhibiting or delaying thepoint at which chyme from the stomach contacts the mucous membranes ofthe intestine.

As seen best in FIGS. 12A-12C, the sleeve 194 comprises a spring-likespiral wire 196 of coated metal or other stiff material embedded in athin flexible sleeve wall 198. The spiral wire 196 therefore renders thesleeve wall 198 more robust and less prone to kinking. Specifically, thespiral loops or windings of the wire 196 provide circumferentialsupport, so the entire sleeve 194 is less likely to collapse or twist. Aproximal end of the sleeve 194 passes through the pyloric sphincter in anecked-down region 200 and connects to the conical anchor 192. To avoidtwisting or closing-off of the necked-down region 200, an integral loop199 of the spiral wire 196 passes through the sphincter along with thesleeve wall 198, and is secured to the conical anchor 192, such as bybeing embedded therein. The necked-down region 200 preferably comprisesa creased structure having a series of longitudinal folds that enablethe region to collapse. The pyloric sphincter may move in and out whichcauses the lumen within the necked-down region 200 to flex, though thewire loop 199 maintains a minimum orifice patency and prevents totalcollapse.

The conical anchor 192 features a number of co-linear circular O-rings202 in graduated sizes that provide good hoop strength to the anchor andprevent migration of the anchor through the pyloric sphincter. Toprevent outward migration of the device back into the stomach, a furthercircular O-ring 204 is integrally formed on the proximal end of theribbed sleeve 194. In a preferred embodiment, the material of the device190 other than possibly the spiral wire 196 is a flexible polymer suchas silicone having sufficient elasticity such that the o-rings 202, 204prevent passage through the pyloric sphincter from either side. Thespiral wire 196 may be a sufficiently flexible metal, such as Nitinol,or a polymer more rigid than the sleeve wall 198.

Implantation of the intragastric device 190 involves collapsing thedevice so it can be introduced through an elongated flexible transoraldelivery tube. The duodenal sleeve 194 may be collapsed by virtue of theflexibility of the spiral wire 196. Similarly, the device can be graspedand pulled to collapse within a similar tube for removal.

FIG. 13 illustrates an intragastric device 220 implanted in the stomachthat spans the pyloric sphincter and extends into the duodenum. Thedevice 220 includes a stomach anchoring member 222, a duodenal anchoringmember 224, flexible cords 226 that extend the length of the device, anda tubular duodenal sleeve 228. As with the earlier embodiments, theintragastric device 220 is non-tissue-piercing and anchors across thepyloric sphincter using flexible, resilient and soft structures thatexpand outward into contact with the surrounding cavity or passage.

The duodenal sleeve 228 extends the full length of the device with aproximal end extending to the stomach anchoring member 222 on thestomach side of the pyloric sphincter and a distal end preferablyextending into the jejunum J (see FIG. 1). As such, the duodenal sleeve228 extends through the pyloric sphincter. Because of its extremelyflexible nature, the duodenal sleeve 228 provides a compressible channelthat flexes with the pyloric sphincter. As usual, the duodenal sleeve228 promotes malabsorption and restriction of the size of the flowpassage through the duodenum and jejunum. Although not shown, the sleeve228 may further include anti-migration ribs as described above withrespect to the sleeve 22 in the embodiment of FIG. 1. A plurality ofanti-migration/anti-kinking rings 230 may be provided spaced along thelength of the duodenal sleeve 228, preferably structurally connected tothe flexible cords 226. Radiopaque markers provided in the rings 230will be useful for ensuring proper deployment of the sleeve 258. In theillustrated embodiment, there are two rings 230 spaced approximatelyhalfway down and toward the distal end of the sleeve 258. The flexiblecords 226 tie together the entire structure, and provideanti-migration/anti-kinking characteristics also. The cords 226 aredesirably formed from strips of silicone or other elastomers. In theillustrated embodiment, there are two such cords 226 diametricallyopposed across the device and extending in parallel the full lengththereof, though more than two may be provided.

With reference to FIG. 14, the device 220 is shown without the duodenalsleeve 228 for clarity. The stomach anchoring member 222 comprises aresilient outer ring 232 having a plurality of grasping tabs 234projecting in a proximal direction. The grasping tabs 234 aid in removalof the device by permitting the device 220 to be easily grasped byforceps, for example. To facilitate removal, the tabs 234 may beprovided with radiopaque markers. An annular flexible membrane 236having a central through hole 238 spans the orifice defined by the outerring 232. The through hole 238 presents an artificial stoma to helprestrict the rate that food can pass from the stomach into the duodenum.Due to the high elasticity of the flexible membrane 236, the throughhole 238 can widen under sufficient pressure, such as when the stomachis very full, though this is desirably just a safety valve, with normalfood intake not overly distorting the flexible membrane. In normal use,the opening 238 defines the size of the orifice through which food canpass into the duodenum. Of course, the diameter of the opening 238 canbe varied for different patients.

The duodenal anchoring member 224 comprises a series of resilient rings240 that are desirably sized to match the contours of the duodenal bulbarea, just distal to the pyloric sphincter. In particular, as seen inFIG. 13, two smaller diameter rings flank a larger central ring todefine a bulge and match the bulb area. As with the outer ring 232 ofthe stomach anchoring member 222, the resilient rings 240 of theduodenal anchoring member 224 preferably comprise an elastomer, such assilicone, and resemble O-rings. If greater anchoring force is deemednecessary, the rings 232, 240 may be formed with metallic cores embeddedwithin a suitable soft coating. One example is a Nitinol ring embeddedwithin a silicone outer covering.

FIG. 15 illustrates a further intragastric device 250 that spans thepyloric sphincter and extends into the duodenum. As with theintragastric device 220 described above, the device 250 includes astomach anchoring member 252, a duodenal anchoring member 254, a pair offlexible cords 256 that extend the length of the device, and a duodenalsleeve 258. Again, a plurality of anti-migration/anti-kinking rings 250are desirably spaced along the length of the duodenal sleeve 258,preferably structurally connected to the flexible cords 256. Theflexible cords 256 tie together the entire structure, and also provideanti-migration/anti-kinking characteristics. In contrast to the earlierembodiment, the gastric device 250 has an enlarged funnel-like stomachanchoring member 252. In a preferred embodiment, the duodenal sleeve 258extends the full length of the device, all the way into the stomachalong the funnel-like anchoring member 252.

The stomach anchoring member 252 comprises a series of resilient ringsthat define its shape. A resilient outer ring 262 having a flexibleannular membrane 264 therein resides just inside the stomach adjacent tothe pyloric sphincter. The outer ring 262 and annular membrane 264function the same as the same elements in the embodiment of FIGS. 13-14,and specifically regulate the rate of flow from the stomach into theduodenal sleeve 258. Progressively larger resilient rings 266 define thefunnel shape of the remainder of the anchoring member 252. The funnelshape thus created conforms to the lower end of the stomach cavity,potentially stimulating the antrum in the process which helps inducesatiety. Proximal portions 268 of the flexible cords 256 continue to theproximal most resilient ring 266. Grasping tabs 270 are desirablyprovided on the proximal end of the device 250, and preferably compriseproximal ends of the extension cords 260. The cords 260 thus provide askeleton of sorts for the device 250 which helps facilitate removalthereof.

The duodenal anchoring member 254 is preferably formed the same as thatdescribed above, with a series of resilient rings 272 that conform tothe upper bulb area of the duodenum. Once implanted, the large sizes ofboth the stomach anchoring member 252 and duodenal anchoring member 254are sufficient to hold the entire device on both sides of the pyloricsphincter without the need for barbs or other tissue-piercing devices.

It should also be stated that any of the embodiments described hereinmay utilize materials that improve the efficacy of the device. Forexample, a number of elastomeric materials may be used including, butnot limited to, rubbers, fluorosilicones, fluoroelastomers,thermoplastic elastomers, or any combinations thereof. The materials aredesirably selected so as to increase the durability of the device andfacilitate implantation of at least six months, and preferably more than1 year.

Material selection may also improve the safety of the device. Some ofthe materials suggested herein, for example, may allow for a thinnerwall thickness and have a lower coefficient of friction than the currentdevice which may aid in the natural passage of the balloon through theGI tract should the device spontaneously deflate.

The implantable devices described herein will be subjected to clinicaltesting in humans. The devices are intended to treat obesity, which isvariously defined by different medical authorities. In general, theterms “overweight” and “obese” are labels for ranges of weight that aregreater than what is generally considered healthy for a given height.The terms also identify ranges of weight that have been shown toincrease the likelihood of certain diseases and other health problems.Applicants propose implanting the devices as described herein into aclinical survey group of obese patients in order to monitor weight loss.

The clinical studies will utilize the devices described above inconjunction with the following parameters.

Materials:

Silicone materials used include 3206 silicone for any shells, inflatablestructures, or otherwise flexible hollow structures. Any fill valveswill be made from 4850 silicone with 6% BaSo₄. Tubular structures orother flexible conduits will be made from silicone rubber as defined bythe Food and Drug Administration (FDA) in the Code of FederalRegulations (CFR) Title 21 Section 177.2600.

Purposes:

the devices are for human implant,

the devices are intended to occupy gastric space while also applyingintermittent pressure to various and continually changing areas of thestomach;

the devices are intended to stimulate feelings of satiety, therebyfunctioning as a treatment for obesity.

General Implant Procedures:

The device is intended to be implanted transorally via endoscope intothe corpus of the stomach.

Implantation of the medical devices will occur via endoscopy.

Nasal/Respiratory administration of oxygen and isoflurane to be usedduring surgical procedures to maintain anesthesia as necessary.

One exemplary implant procedure is listed below.

a) Perform preliminary endoscopy on the patient to examine the GI tractand determine if there are any anatomical anomalies which may affect theprocedure and/or outcome of the study.

b) Insert and introducer into the over-tube.

c) Insert a gastroscope through the introducer inlet until the flexibleportion of the gastroscope is fully exited the distal end of theintroducer.

d) Leading under endoscopic vision, gently navigate the gastroscope,followed by the introducer/over-tube, into the stomach.

e) Remove gastroscope and introducer while keeping the over-tube inplace.

f) OPTIONAL: Place the insufflation cap on the over-tubes inlet, insertthe gastroscope, and navigate back to the stomach cavity.

g) OPTIONAL: Insufflate the stomach with air/inert gas to providegreater endoscopic visual working volume.

h) Collapse the gastric implant and insert the lubricated implant intothe over-tube, with inflation catheter following if required.

i) Under endoscopic vision, push the gastric implant down the over-tubewith gastroscope until visual confirmation of deployment of the deviceinto the stomach can be determined.

j) Remove the guide-wire from the inflation catheter is used.

k) If inflated: Inflate the implant using a standard BioEntericsIntragastric Balloon System (“BIB System”) Fill kit.

L) Using 50-60 cc increments, inflate the volume to the desired fillvolume.

m) Remove the inflation catheter via over-tube.

n) Inspect the gastric implant under endoscopic vision for valveleakage, and any other potential anomalies. Record all observations.

o) Remove the gastroscope from over-tube.

p) Remove the over-tube from the patient.

End Point Criteria:

-   -   Weight Loss    -   Comprehensive Metabolic Panel (CMP)    -   HbA1C    -   Lipid Panel    -   Tissue Samples/Response

Unless otherwise indicated, all numbers expressing quantities ofingredients, properties such as molecular weight, reaction conditions,and so forth used in the specification and claims are to be understoodas being modified in all instances by the term “about.” Accordingly,unless indicated to the contrary, the numerical parameters set forth inthe specification and attached claims are approximations that may varydepending upon the desired properties sought to be obtained. At the veryleast, and not as an attempt to limit the application of the doctrine ofequivalents to the scope of the claims, each numerical parameter shouldat least be construed in light of the number of reported significantdigits and by applying ordinary rounding techniques.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope of the disclosure are approximations, the numericalvalues set forth in the specific examples are reported as precisely aspossible. Any numerical value, however, inherently contains certainerrors necessarily resulting from the standard deviation found in theirrespective testing measurements.

The terms “a,” “an,” “the” and similar referents used in the context ofdescribing the invention (especially in the context of the followingclaims) are to be construed to cover both the singular and the plural,unless otherwise indicated herein or clearly contradicted by context.Recitation of ranges of values herein is merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range. Unless otherwise indicated herein, eachindividual value is incorporated into the specification as if it wereindividually recited herein. All methods described herein can beperformed in any suitable order unless otherwise indicated herein orotherwise clearly contradicted by context. The use of any and allexamples, or exemplary language (e.g., “such as”) provided herein isintended merely to better illuminate the invention and does not pose alimitation on the scope of the invention otherwise claimed. No languagein the specification should be construed as indicating any non-claimedelement essential to the practice of the invention.

Groupings of alternative elements or embodiments of the inventiondisclosed herein are not to be construed as limitations. Each groupmember may be referred to and claimed individually or in any combinationwith other members of the group or other elements found herein. It isanticipated that one or more members of a group may be included in, ordeleted from, a group for reasons of convenience and/or patentability.When any such inclusion or deletion occurs, the specification is deemedto contain the group as modified thus fulfilling the written descriptionof all Markush groups used in the appended claims.

Certain embodiments are described herein, including the best mode knownto the inventors for carrying out the invention. Of course, variationson these described embodiments will become apparent to those of ordinaryskill in the art upon reading the foregoing description. The inventorexpects skilled artisans to employ such variations as appropriate, andthe inventors intend for the invention to be practiced otherwise thanspecifically described herein. Accordingly, this invention includes allmodifications and equivalents of the subject matter recited in theclaims appended hereto as permitted by applicable law. Moreover, anycombination of the above-described elements in all possible variationsthereof is encompassed by the invention unless otherwise indicatedherein or otherwise clearly contradicted by context.

Furthermore, references may have been made to patents and printedpublications in this specification. Each of the above-cited referencesand printed publications are individually incorporated herein byreference in their entirety.

Specific embodiments disclosed herein may be further limited in theclaims using “consisting of” or “consisting essentially of” language.When used in the claims, whether as filed or added per amendment, thetransition term “consisting of” excludes any element, step, oringredient not specified in the claims. The transition term “consistingessentially of” limits the scope of a claim to the specified materialsor steps and those that do not materially affect the basic and novelcharacteristic(s). Embodiments of the invention so claimed areinherently or expressly described and enabled herein.

In closing, it is to be understood that the embodiments of the inventiondisclosed herein are illustrative of the principles of the presentinvention. Other modifications that may be employed are within the scopeof the invention. Thus, by way of example, but not of limitation,alternative configurations of the present invention may be utilized inaccordance with the teachings herein. Accordingly, the present inventionis not limited to that precisely as shown and described.

What is claimed is:
 1. A transorally inserted, intragastric device forthe treatment of obesity, comprising: a stomach anchoring member havingno tissue piercing elements, a collapsed, delivery size, and anexpanded, deployed size larger than a pyloric sphincter, said stomachanchoring member being resiliently biased to move from said collapseddelivery size to said expanded deployed size; a duodenal anchoringmember having no tissue piercing elements, a collapsed, delivery size,and an expanded, deployed size larger than a pyloric sphincter saidduodenal anchoring member being resiliently biased to move from saidcollapsed delivery size to said expanded deployed size; an elongatedduodenal sleeve for placement in the duodenum having a tubular body withproximal and distal ends, the proximal end extending to the stomachanchoring member on the stomach side of the pyloric sphincter, andforming a compressible channel through the pyloric sphincter; andwherein the device is formed of a material that will resist structuraldegradation over a period of at least six months within thegastrointestinal tract.
 2. The device of claim 1, wherein the stomachanchoring member comprises a funnel-shaped structure that extends intothe stomach, and wherein the duodenal sleeve continues and widens in aproximal direction along the funnel-shaped structure.
 3. The device ofclaim 2, wherein the stomach anchoring member comprises a plurality ofresilient rings sufficiently compressible to be delivered transorally,and sufficiently large to spring outward to form the funnel-shapedstructure in contact with the antrum area of the stomach.
 4. The deviceof claim 1, wherein the duodenal anchoring member comprises a pluralityof resilient rings sufficiently compressible to be deliveredtransorally, and sufficiently large to spring outward into contact witha duodenal bulb area of the duodenum, the plurality of resilient ringsbeing differently sized and having a central larger ring such that theduodenal sleeve has a bulge in the area of the duodenal anchoringmember.
 5. The device of claim 1, further including a plurality ofspaced resilient rings positioned along a length of the duodenal sleeve.6. The device of claim 1, further including a flexible annular membranespanning the stomach anchoring member and having a central through holethat defines the flow orifice from the stomach into the duodenal sleeve.7. The device of claim 1, further including a plurality of grasping tabsprojecting proximally from the stomach anchoring member.
 8. Atransorally inserted, intragastric device for the treatment of obesity,comprising: a stomach anchoring member comprising at least one resilientring sufficiently compressible to be delivered transorally, andsufficiently large to spring outward into contact with the lower stomachadjacent the pyloric sphincter; a duodenal anchoring member comprising aplurality of resilient rings sufficiently compressible to be deliveredtransorally, and sufficiently large to spring outward into contact witha duodenal bulb area of the duodenum; and an elongated duodenal sleevefor placement in the duodenum having a tubular body with proximal anddistal ends, the proximal end extending to the stomach anchoring memberon the stomach side of the pyloric sphincter, and forming a compressiblechannel through the pyloric sphincter; wherein the device is formed of amaterial that will resist structural degradation over a period of atleast six months within the gastrointestinal tract.
 9. The device ofclaim 8, wherein the stomach anchoring member comprises a funnel-shapedstructure that extends into the stomach, and wherein the duodenal sleevecontinues and widens in a proximal direction along the funnel-shapedstructure.
 10. The device of claim 8, wherein the stomach anchoringmember comprises a plurality of the resilient rings forming afunnel-shaped structure in contact with the antrum area of the stomach.11. The device of claim 8, further including a flexible annular membranespanning the resilient ring of the stomach anchoring member and having acentral through hole that defines the flow orifice from the stomach intothe duodenal sleeve.
 12. The device of claim 11, wherein the stomachanchoring member comprises a plurality of the resilient rings sizedprogressively larger in the proximal direction to form a funnel-shapedstructure that extends into the stomach, and wherein the flexibleannular membrane spans the resilient ring closest to the duodenalanchoring member.
 13. The device of claim 8, wherein the stomachanchoring member comprises a funnel-shaped structure that extends intothe stomach and includes a flexible annular membrane.
 14. The device ofclaim 8, wherein the plurality of resilient rings of the duodenalanchoring member spring outward into contact with a duodenal bulb areaof the duodenum, the plurality of resilient rings being differentlysized and having a central larger ring such that the duodenal sleeve hasa bulge in the area of the duodenal anchoring member.
 15. The device ofclaim 8, wherein the stomach anchoring member comprises aparabolic-shaped structure that extends into the stomach.